Pill Identifier App

Meglumine Antimoniate (Systemic)


VA CLASSIFICATION
Primary: AP109

Commonly used brand name(s): Glucantim; Glucantime.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

*Not commercially available in the U.S.

Not commercially available in Canada.



Category:


Antiprotozoal (systemic)—

Indications

Note: Because meglumine antimoniate is not commercially available in the U.S. or Canada, the bracketed information and the use of the superscript 1 in this monograph reflect the lack of labeled (approved) indications for this medication in these countries.

General considerations
{35}Meglumine antimoniate is a pentavalent antimony compound with properties similar to sodium stibogluconate, another pentavalent antimony compound {07} {09} that is available in the U.S. through the Centers for Disease Control (CDC). {10} {31} These medications are considered first-line agents in the treatment of leishmaniasis. Their efficacy and toxicity are thought to be related to their content of pentavalent antimony. {07} {09}

Accepted
{35}[Leishmaniasis, visceral (treatment)]1—Meglumine antimoniate is used as a primary agent in the treatment of visceral leishmaniasis (kala-azar or black sickness) caused by the following species of the Leishmania donovani complex: L. donovani donovani, L. d. infantum, and L. d. chagasi . {01} {02} {03} {04} {05} {06} {07} {08} {09} {10} {23} {29} {31}

[Leishmaniasis, cutaneous (treatment)]1—Meglumine antimoniate is used in the treatment of cutaneous leishmaniasis of the Old World (also known as Oriental sore) caused by L. tropica {08} {09} {10} {23} or L. major . {08} {09} {10} {23} It is also used in the treatment of cutaneous leishmaniasis of the New World caused by numerous species and strains of Leishmania including L. amazonensis,{08}{23} L. braziliensis,{08}{09}{10}{11}{12}{13}{14}{16} L. guyanensis, {31}L. mexicana {08} {09} {10} {11} {16} {23} (which causes Bay sore or chiclero ulcer) {23} {36}, L. panamensis (which causes the disease known locally in Panama as ``ulcera de Bejuco''), {08} {09} {23} {36} and L. peruviana {08} {23} (which causes the disease seen in the Peruvian Andes known locally as``uta''). {23} {36}
—Because cutaneous leishmanial lesions may heal without specific therapy, treatment may not always be necessary. {30} {33} However, treatment may be indicated to decrease the risk of metastases to the mucosa, to other skin sites, or to the viscera; to minimize or prevent the local morbidity caused by persistent or large skin lesions especially those found on the face, ears, or near the joints; or to decrease the reservoir of infection in certain geographic areas where the infected humans are important reservoir hosts. {30} Systemic therapy with meglumine antimoniate may be indicated for primary lesions caused by L. amazonensis to prevent mucosal or diffuse cutaneous leishmaniasis. and for primary lesions caused by the organisms in the L. braziliensis species complex (L. braziliensis, L. panamensis, L. peruviana ) to prevent mucosal leishmaniasis. {09} {33}
—Decisions concerning the initial clinical management of patients with cutaneous leishmaniasis are usually made without knowing the species of the causative organism. In practice, most persons with leishmanial lesions are treated, especially if morbidity is anticipated. {30}

[Leishmaniasis, mucosal (treatment)]1—Meglumine antimoniate is used in the treatment of mucosal leishmaniasis of the New World caused by L. amazonensis, {08} {23} {31}L. braziliensis (which causes the disease known in Brazil as ``espundia''), {08} {09} {10} {23} {36}L. guyanensis, {23} {31} or L. panamensis. {09}

[Leishmaniasis, diffuse cutaneous (treatment)]1—Meglumine antimoniate is used in the treatment of diffuse cutaneous leishmaniasis caused by L. amazonensis {08} and L. pifanoi . {32}

—Not all species or strains of this particular organism may be susceptible to meglumine antimoniate.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:


Chemical
    Pentavalent antimony compound chemically similar to and exhibiting the same properties as sodium stibogluconate {05} {07} {09} {16}
Molecular weight—
    366.0 {07}

Mechanism of action/Effect:

Leishmanicidal; {08} the mechanism of action of meglumine antimoniate is unknown, but may involve inhibition of the parasite's glycolytic and fatty acid oxidative activity resulting in decreased reducing equivalents for antioxidant defense and decreased synthesis of adenosine triphosphate (ATP), which is the energy required for the survival of the parasite. Diminished energy production eventually leads to the death of the protozoa. {15}

Meglumine antimoniate has been shown to be ineffective in vitro against the free flagellated forms of the parasite. However, it has not been determined whether meglumine antimoniate has selective activity against the intracellular forms, or whether small amounts of the medication are converted intracellularly into a potent trivalent inhibitor of the parasite's glycolytic enzymes. {08}

Absorption:

Poorly absorbed from the gastrointestinal tract; must be given parenterally. {08} {24}

Distribution:

Found in high concentrations in the plasma, liver, and spleen. {24}

Mean total apparent volume of distribution—0.22±0.057 L/kg of body weight. {17}

Biotransformation:

Hepatic; small amounts of pentavalent antimony in meglumine antimoniate are reduced to the trivalent state. {24}

Half-life:


Approximate mean half-life following an intramuscular administration of meglumine antimoniate in a dose that provides 10 mg/kg of pentavalent antimony:

Initial absorption phase: 51 minutes

Rapid elimination phase: 2.02 hours

Slow elimination phase: 76 hours. {17}


Time to peak concentration:

Approximately 2 hours following intramuscular administration of meglumine antimoniate in a dose that provides 10 mg/kg of pentavalent antimony. {17}

Peak serum concentration

Approximately 9 to 12 mg per L following intramuscular administration of meglumine antimoniate in a dose that provides 10 mg/kg of pentavalent antimony. {17}

Elimination:
    Renal—Rapid; up to 50% is excreted unchanged in the urine within 24 hours following a single parenteral administration; {05} {17} {24} excretion is complete within 48 hours. {05} {08} {17}


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans. {08}

Studies have not been done in animals.

Breast-feeding

It is not known whether meglumine antimoniate is distributed into breast milk. However, there is one case report of distribution of a small amount of antimony into breast milk following intravenous administration of sodium stibogluconate, a pentavalent antimony compound similar to meglumine antimoniate, to a lactating woman with leishmaniasis. {07} {18}

Pediatrics

Appropriate studies on the relationship of age to the effects of meglumine antimoniate have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date. On a weight-for-weight basis, children require more pentavalent antimony than adults. Tolerance of this compound is also better in children than in adults. {09}


Geriatrics


Appropriate studies on the relationship of age to the effects of meglumine antimoniate have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

{35}
Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

» Agents that prolong the QT interval,{31} such as certain antiarrhythmics (types IA, IC, III) or tricyclic antidepressants{34}    (concurrent use with meglumine antimoniate may further prolong the QT interval and may increase the risk of arrhythmia)


Alcohol{31}    (concurrent use with meglumine antimoniate may potentiate the risk of hepatotoxicity)



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
» Electrocardiography (ECG)    (may cause variable, {19} dose-dependent, and reversible ECG changes {08} {19} {20} {21} such as an increase in the amplitude of the P wave, {24} T wave inversion {19} {20} {24}(or a decrease in its height), {30} {31} S-T segment elevation, {19} {20} {24} or prolongation of the QT interval; these changes also may occur with prolonged treatment {08} {21} {24} {28})

With physiology/laboratory test values
» Alanine aminotransferase (ALT [SGPT]){20} and
» Alkaline aminotransferase{20} and
» Aspartate aminotransferase (AST [SGOT]){20} and
» Amylase, serum{22} and
» Lipase, serum{22}    (values may be transiently elevated {20} {22})


Complete Blood Counts (CBC)    (a decrease in hemoglobin or leukocyte concentrations has been reported occasionally {03} {26})


» Blood urea nitrogen (BUN) and
» Creatinine, serum    (concentrations may be increased {25} {27})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist {35}
Sensitivity to meglumine antimoniate or to its inactive ingredients, sulfites{04}{05}
» Cardiac disease,{04}{05}{08} especially conduction defects, or history of{32}    (meglumine antimoniate may cause cardiac arrhythmias {08} {09} {19} {20} {21} {24} {28} {30})


» Hepatic function impairment{04}{05}{08}{20}    (meglumine antimoniate may cause a transient increase in AST [SGOT], ALT [SGPT], and alkaline phosphatase {20} {30})


» Pancreatitis, or history of{21}{22}    (meglumine antimoniate may cause a transient increase in serum lipase and amylase)


» Renal function impairment{04}{05}{07}{09}{25}{27}    (renal tubular dysfunction has been reported; patients with impaired renal function may be at increased risk of toxicity because of decreased clearance of meglumine antimoniate {25} {27} {30})


Caution should be used when giving large doses of meglumine antimoniate in elderly, debilitated, or malnourished patients because they are more likely to experience serious side effects{25}{27}{30}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

{35}Complete Blood Counts (CBC)    (because meglumine antimoniate has been occasionally reported to cause anemia or leukopenia, a complete blood count should be done prior to and weekly during treatment {30})


» Electrocardiogram (ECG){05}{08}{28}    (may not be necessary in otherwise healthy children receiving only 20 days of meglumine antimoniate therapy; however, for patients requiring more than 20 days of therapy {30} at a dose of 20 mg of pentavalent antimony per kg (mg/kg) of body weight per day, or for patients receiving a dose higher than 20 mg/kg for more than 10 days, {28} ECG monitoring is recommended and should be done twice weekly starting on the third week of therapy; other medical experts have suggested every 3 to 4 days from the start of therapy; {28} twice weekly or even frequent monitoring from the start of therapy may be necessary for the elderly, obese, or persons with underlying cardiac, hepatic, or renal disease; {30} in the event that Stokes-Adams attacks develop and sudden cardiac collapse occurs, treatment with meglumine antimoniate should be stopped and atropine should be started; atropine should be administered intravenously at a dose of 0.5 to 1.5 mg followed by intramuscular administration of 0.5 to 1 mg every 3 hours; if treatment with atropine is unsuccessful, isoprenaline or atrial pacing should be considered {28})


» Hepatic function tests    (hepatic function determinations, including serum alanine aminotransferase [ALT (SGPT)], serum alkaline aminotransferase, and serum aspartate aminotransferase [AST (SGOT)], may be required prior to and weekly during therapy; {08} {20} {30} elevated hepatic enzyme values usually do not limit therapy; however, if the value of one of the serum aminotransferases reaches five times the upper limit of normal, therapy should be temporarily interrupted; some clinicians would discontinue therapy if the value reaches three to four times the upper limit of normal {30})


» Amylase, serum and
» Lipase, serum{21}{22}    (should be monitored prior to and weekly during treatment; if serum amylase value reaches over 4-fold the upper limit of normal, or if serum lipase value reaches over 15-fold the upper limit of normal, and if these rises in enzyme levels occur rapidly, or are associated with abdominal pain, nausea, and vomiting, therapy should be temporarily interrupted {22})


» Renal function tests    (renal function determinations, including blood urea nitrogen [BUN] and serum creatinine, may be required prior to and weekly during treatment {05} {21} {22} {25} {28})




Side/Adverse Effects

Note: Treatment with pentavalent antimony compounds is usually well tolerated. However, the general condition of patients with visceral leishmaniasis probably influences the degree to which side effects of the medication may be manifested. Also, malnutrition is common in these patients and their immune system is often impaired, making them more susceptible to intercurrent infections. {26}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Cardiotoxicity (irregular heartbeat){04}{05}{08}{09}{19}{20}
    
hepatotoxicity {04}{05}{08}{09}{26}(increased level of hepatic enzymes)
    
pancreatitis (fever; nausea; pain in the upper abdominal area extending to the back; vomiting){20}{21}{22}

Incidence rare
    
Anaphylactoid reaction (changes in facial skin color; fainting or loss of consciousness; fast or irregular breathing; husky voice; puffiness or swelling of the eyelids or around the eyes; shortness of breath, troubled breathing, tightness in chest, and/or wheezing; skin rash and/or itching){04}{05}{24}
    
blood dyscrasias such as anemia (troubled breathing, exertional; unusual tiredness or weakness), and leukopenia (fever or chills; cough or hoarseness){03}{24}{26}
    
dyspnea (difficulty in breathing){08}
    
facial edema (swelling of the face){08}
    
nephrotoxicity (decreased amount and frequency of urination){04}{05}{08}{09}{26}{27}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Anorexia {07}{09}{20}{26}(loss of appetite)
    
arthralgia (joint pain){11}{19}{20}{26}
    
fever and chills {04}{05}{16}{20}
    
gastrointestinal disturbances (abdominal or stomach pain; nausea; vomiting){04}{05}{07}{09}{16}{19}{26}
    
headache {07}{09}{19}{20}{26}
    
lethargy (drowsiness){09}{26}
    
malaise (general feeling of discomfort){09}{26}
    
myalgia (muscle pain){04}{05}{07}{09}{16}{19}{26}
    
spasmodic cough{04}{05}{24}





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Meglumine Antimoniate (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before receiving this medication
»   Conditions affecting use, especially:
Sensitivity to meglumine antimoniate or sulfites
Other medications, especially agents that prolong the QT interval
Other medical problems, especially cardiac disease, hepatic function impairment, pancreatitis, or renal function impairment

Proper use of this medication
Importance of receiving this medication for full course of therapy and on a regular schedule

» Proper dosing

Precautions while receiving this medication
Regular visits to physician to check progress

» Checking with physician if symptoms get worse


Side/adverse effects
Signs of potential side effects, especially, cardiotoxicity; hepatotoxicity; pancreatitis; anaphylactoid reaction; blood dyscrasias, such as anemia and leukopenia; dyspnea; facial edema; and nephrotoxicity


General Dosing Information
{35}Meglumine antimoniate should be administered parenterally {08} under medical supervision. {09} Intramuscular doses are expressed in terms of the equivalent amount of pentavalent antimony. All doses, which are weight-related, are suitable for both adults and children. {08}

Duration of treatment varies from one endemic area to another. The World Health Organization (WHO) recommends that treatment should be continued for 2 weeks after apparent parasitological cure, with the exact length of treatment being individually determined for each country and for each patient. {09} {15}

Treatment with pentavalent antimony is usually well-tolerated, but if serious side effects occur (in most cases, related to cardiac, hepatic, {09} or pancreatic toxicity {31} {32}), treatment may have to be interrupted temporarily. If relapses occur, patients should first be treated again with an antimonial. If the response is still unsatisfactory, or in cases of primary unresponsiveness, alternative agents, such as amphotericin B or pentamidine, should be considered. {09}

Intralesional injection of meglumine antimoniate is effective for early nodular lesions of cutaneous leishmaniasis, except those caused by L. aethiopica, L. amazonensis, or organisms of the L. braziliensis species complex. Infiltration must be thorough and should produce complete blanching of the base of the lesion. However, systemic therapy with meglumine antimoniate is required for inflamed or ulcerated lesions and those lesions that are situated where scarring can result in disability or disfigurement. Systemic therapy is also necessary for lesions with lymphangitis or cartilage involvement. {08} Further, WHO recommends systemic therapy with meglumine antimoniate for all primary lesions caused by L. amazonensis or organisms of the L. braziliensis species complex because these lesions have the propensity to evolve into the more severe forms of leishmaniasis. Primary lesions caused by L. amazonensis may develop into the mucosal or diffuse cutaneous form of leishmaniasis, while primary lesions caused by organisms of the L. braziliensis species complex may develop into the mucosal form of leishmaniasis. {09} {31}

A useful adjunct in the treatment of certain cases of simple cutaneous leishmaniasis is the local application of heat to the lesion since this has been found to accelerate the healing process. {09}

For visceral leishmaniasis, patients with a favorable clinical response should have clinical and laboratory follow-up 1.5, 3, 6, and 12 months after completion of therapy. The best indicator of permanent cure is freedom from a clinical relapse for at least 6 months of follow-up. {30}

For cutaneous leishmaniasis, cutaneous lesions commonly demonstrate only a partial clinical response during a 20-day course of therapy. These lesions may not completely heal (complete reepithelialization and the absence of macroscopic wound inflammation) until weeks after completion of therapy. Therefore, patients should be reevaluated 6 weeks after therapy is completed for signs of clinical response. These patients should also be monitored for 1 year for signs of relapse. Retreatment should be considered if the lesions have not diminished by at least 75% in area by 6 weeks after the end of therapy. The decision to repeat treatment should be based on clinical criteria, not on the presence or absence of demonstrable parasites. {30}

For mucosal leishmaniasis, the initial response to therapy should be determined 3 months after the end of therapy. Patients with this form of leishmaniasis should also be monitored for relapse for several years.

Diet/Nutrition
A protein-rich diet should be provided throughout treatment with meglumine antimoniate and, where possible, iron depletion and other specific deficiencies should be corrected beforehand. {08}

For treatment of adverse effects {35}
Recommended treatment consists of the following

   • Reduction in dose or discontinuation of treatment. {06}.
   • For Stokes-Adams attacks or cardiac block, atropine should be administered intravenously at a dose of 0.5 to 1.5 mg, followed by intramuscular administration of 0.5 to 1 mg every 3 hours; if treatment with atropine is unsuccessful, isoprenaline or atrial pacing should be considered. {28}


Parenteral Dosage Forms

Note: Because meglumine antimoniate is not commercially available in the U.S. or Canada, the bracketed uses and the use of the superscript 1 in the Dosage Forms section reflect the lack of labeled (approved) indications for this medication in these countries.

MEGLUMINE ANTIMONIATE FOR INJECTION

Usual adult dose
[Leishmaniasis]1
Systemic therapy: Intramuscular, 20 mg of pentavalent antimony per kg of body weight per day for twenty to twenty-eight days. This regimen may be repeated or continued when necessary. A longer duration may be needed for some forms of leishmaniasis. {10} {30} {32} WHO recommends that treatment should be continued for at least two weeks after anticipated parasitological cure, the exact length of treatment to be determined for each country and for each patient. {09}

Local therapy: Injection into the base of the lesion of 1 to 3 mL (300 to 900 mg) of meglumine antimoniate. This may be repeated one or two times, if necessary, at one- or two- day intervals. Infiltration of the medication into the lesion must produce complete blanching at the base of the lesion. {09}


Usual adult prescribing limits
Recent studies have shown that giving pentavalent antimony without an upper limit on the daily dose is more effective and is not substantially more toxic than the regimen with lower daily doses. {30}

Usual pediatric dose
See Usual adult dose. {09} {10} {30}

Size(s) usually available:
U.S.—
Not commercially available.

Canada—
Not commercially available.

Other—


1.5 grams meglumine antimoniate (equivalent to 425 mg of pentavalent antimony) per 5 ml (Rx) [Glucantim ( Italy)] [Glucantime (France) (sulfites)]{04}{05}{06}{32}

Packaging and storage:
Store ampules below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing. {08}

Stability:
Meglumine antimoniate may deteriorate with age. {08}



Developed: 02/24/1995



References
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